Description
Decitabine injection is used to treat myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells. It also treats certain types of anemia. Decitabine is an antineoplastic (cancer medicine).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of decitabine injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of decitabine in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Cholera Vaccine
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Rotavirus Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infection—May decrease your body's ability to fight an infection.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. You may receive this medicine either as a 3-day or 5-day regimen.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.
Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
Decitabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
If you plan to have children, talk with your doctor before receiving this medicine. Some men receiving this medicine have become infertile (unable to have children).
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bladder pain
- bleeding after defecation
- bleeding gums
- blood in the urine or stools
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision
- body aches or pain
- chest pain
- chills
- congestion
- cough
- coughing that sometimes produces a pink frothy sputum
- decreased urination
- difficult, burning, or painful urination
- difficult, fast, or noisy breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- drowsiness
- dry mouth or throat
- fainting
- fast or irregular heartbeat
- feeling unusually cold
- fever
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- hives or welts, itching, skin rash
- hoarseness
- increased hunger
- increased sweating
- increased thirst
- increased urination
- lightheadedness
- loss of appetite
- loss of consciousness
- lower back or side pain
- mood or mental changes
- muscle pain, cramps, spasms, or twitching
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- pain, redness, swelling, tenderness, or warmth on the skin
- pale skin
- pinpoint red spots on the skin
- redness or pain at the catheter site
- runny nose
- seizures
- shivering
- small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
- small red or purple spots on the skin, lips or in the mouth
- sneezing
- sore mouth, tongue, or throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain and bloating
- sunken eyes
- swelling of the face, hands, ankles, feet, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- trembling
- trouble in swallowing
- troubled breathing with exertion
- uncomfortable swelling around the anus
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- vomiting
- weakness or heaviness of the legs
- wrinkled skin
- yellow eyes or skin
Less common
- Collection of blood under the skin
- deep, dark purple bruise
- diarrhea
- pain or tenderness around the eyes and cheekbones
- pain, warmth, or burning in the fingers, toes, and legs
- problems with vision or hearing
- skin scrape or burn
- stuffy nose
- swelling at the injection site
Incidence not known
- Fever sores on the skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Anxiety
- back pain
- belching
- bumps on the skin
- chest discomfort
- constipation
- falls
- hair loss or thinning of the hair
- heartburn
- indigestion
- loose stools
- muscle stiffness
- pain in the arms or legs
- pain in joints
- stomach discomfort or upset
- swelling or inflammation of the mouth
- trouble sleeping
- unusual drowsiness, dullness, or feeling of sluggishness
Less common
- Difficulty in moving
- general feeling of discomfort or illness
- postnasal drip
- pressure in the stomach
- swollen joints
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20070616
